ACUMED ANATOMIC RADIAL HEAD SYSTEM MANUFACTURED BY ACUMED LLC

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ACUMED ANATOMIC RADIAL HEAD SYSTEM

Request for Information Form	Contact Information
Company Name	ACUMED LLC
Address	5885 NW CORNELIUS PASS RD.
City, State, Zip	HILLSBORO, OR 97124
Country	US
FDA Owner/Operator Phone	503-627-9957
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	KWI
FDA Classification Name	PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
FDA Device Classification Code	Standards
FDA Regulation Number	888.3170
FDA Common Generic Name	PROTHESIS, ELBOW JOINT RADIAL HEAD
FDA Proprietary Device Name	ACUMED ANATOMIC RADIAL HEAD SYSTEM
FDA Owner / Operator Number	9001805
FDA Owner / Operator Name	ACUMED LLC
FDA Establishment Registration Number	3025141
FDA Registered Establishment Name	ACUMED LLC
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-22-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ACUMED LLC

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 AUSTIN, TX 78754 US 512-836-5001 1513 / 512-836-5001 1513	ASCENSION MODULAR RADIAL HEAD	RADIAL HEAD PROSTHESIS
2	BIOMET UK LTD. MURDOCK ROAD DORCAN INDUSTRIAL ESTATE SWINDON WILTSHIRE, SN3 5HY UK 44-165-6655221 / 441-656-655221	BIOMET MERCK	STERILE RADIAL HEAD REPLACEMENT PROSTHESIS
3	BIOMET UK LTD. WATERTON INDUSTRIAL ESTATE BRIDGEND SOUTH WALES, CF31 3XA UK 44-165-6655221 / 441-656-655221	BIOMET MERCK	STERILE RADIAL HEAD REPLACEMENT PROSTHESIS
4	BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 WARSAW, IN 46581 US 574-267-6639 / 574-372-1742	MODULAR RADIAL HEAD	VARIOUS TYPES OF ELBOW PROSTHESIS
5	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581 US 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF ELBOW PROSTHESES, HEMI-RADIAL, POLYMER
6	HOWMEDICA INTERNATIONAL S. DE R.L., RAHEEN BUSNIESS PARK LIMERICK, EI 269-385-2600 / 201-831-5002	MULTIPLE	RADIAL HEAD
7	KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. WARRENSVILLE HEIGHTS, OH 44128 US 216-587-4400 / 216-587-4400	KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT	RADIAL HEAD IMPLANT
8	KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD STE 180 CARLSBAD, CA 92011 US 609-275-0500 / 760-448-1706	KATALYST RADIAL HEAD IMPLANT	PASSIVE ORTHOPEDIC IMPLANT, ELBOW
9	SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. MORRISVILLE, PA 19067 US 212-583-0250 / 215-428-1791 254	RHEAD	ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
10	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US 901-396-2121 / 901-399-5373	MULTIPLE	VARIOUS TYPES OF ELBOW PROSTHESES
11	WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US 901-867-4732 / 901-867-9971	METALLIC RADIAL HEAD IMPLANTS	METALLIC RADIAL HEAD
12	ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. PARSIPPANY, NJ 07054 US 800-613-6131 / 201-818-1800	UPPER EXTREMITY	RADIAL HEAD REPLACEMENT